BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø9 SM 130° L200 TAN

    MDR report key: 8780747 · Received July 11, 2019

    Report

    Report Number
    8030965-2019-66157
    Event Type
    Injury
    Date Received
    July 11, 2019
    Report Date
    June 13, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    UDI-DI
    07611819292888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 472.431S, LOT: L820111, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 27.MAR.2018, EXPIRY DATE: 01.MAR.2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE RECEIVED PFNA NAIL IS BROKEN APART AT THE SHAFT NEAR THE SLOTTED HOLE. FURTHERMORE, THERE ARE SEVERAL MECHANICAL DAMAGES VISIBLE ON THE SURFACE. IN GENERAL IS THE DEVICE IS IN A VERY USED CONDITION WITH DISCOLORATIONS AND SCRATCHES ALL OVER. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. DIMENSIONAL INSPECTION: OUTER DIAMETER HEAD, OUTER DIAMETER SHAFT (NEAR BREAKAGE POINT) AND INNER DIAMETER (NEAR BREAKAGE POINT) WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS AS PER RELEVANT DRAWINGS. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FURTHERMORE, AS INDICATED IN THE MANUFACTURING DOCUMENTS, THE CORRECT MATERIAL (TAN/TI6AL7NB) WAS USED ACCORDING ISO 5832-11 SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE NAIL WAS FOUND BROKEN. REVIEWING ATTACHED X-RAYS, THE COMPLAINT DESCRIPTION CAN ALSO BE CONFIRMED. THE FOR THE COMPLAINT RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE AND FOUND TO BE WITHIN SPECIFICATIONS. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN MARCH 2018, ALL DEVICES ARE DISTRIBUTED AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART- AND LOT NUMBER COMBINATION. THIS AND THE FINDINGS ABOVE LET US EXCLUDE A MANUFACTURING RELATED ISSUE. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS BREAKAGE. WE CAN ONLY ASSUME THAT ANY OCCURRENCE DURING THE HEALING PROCESS, E.G. NON-UNION, DELAYED UNION, MAL-UNION, OVERLOADING OF THE OSTEOSYNTHESIS OR A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO A FATIGUE FAILURE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    CONCOMITANT DEVICE REPORTED: PFNA BLADE (PART# 04.027.034S, LOT# 3L04768, QUANTITY 1), LOCKING SCREW (PART# 04.005.524, LOT# 2L09729, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, A SMALL PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAIL WAS NOTED BROKEN. INITIALLY PATIENT WAS IMPLANTED WITH PFNA ON (B)(6) 2019. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019 AND WAS IMPLANTED WITH NEW PFNA. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN HELICAL BLADE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) AND UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) PFNA NAIL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574599 PFNA Ø9 SM 130° L200 TAN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH L820111 07611819292888

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN| PFNA BLADE PERF L95 TAN| UNK - NAIL HEAD ELEMENTS: PFNA BLADE| UNK - SCREWS: LOCKING| UNK - NAIL HEAD ELEMENTS: PFNA BLADE| UNK - SCREWS: LOCKING